Condition category
Respiratory
Date applied
25/03/2015
Date assigned
13/04/2015
Last edited
14/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Airway management is poorly achieved by para-medic and inexperienced medical staff. The aim of this study is to find out whether users perform better with a new device (Tulip GT airway) or a conventional mask (Guedel with facemask airway)? This new device may have a place in out-of-hospital and in-hospital resuscitation.

Who can participate?
Inexperienced users annually trained with Basic Life Support skills (BLS).
Adults patients undergoing scheduled surgery.

What does the study involve?
A group of 60 inexperienced users who are trained in BLS skills are introduced to a new airway device that has already been tested on manikins and in other studies. All patients undergoing surgery will be allocated to one device and then to the other.

What are the possible benefits and risks of participating?
The potential benefits of the new device are ease of use, secure, hands free, has a steep learning curve and cost. Neither device protects the airway from aspiration of stomach contents but all patients are undergoing elective surgery and anyone with this risk is excluded from the study.

Where is the study run from?
North West London Hospitals NHS Trust (UK)

When is the study starting and how long is it expected to run for?
From April 2013 to July 2017.

Who is funding the study?
North West London Hospitals NHS Trust (UK)

Who is the main contact?
Dr Peter Neville

Trial website

Contact information

Type

Public

Primary contact

Dr Peter Neville Robinson

ORCID ID

Contact details

6 Robin Grove
London
N6 6NY
United Kingdom
+44 (0)7770224064
pnrfmt@msn.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The Tulip GT airway versus Guedel with facemask airway: a randomised crossover clinical study using inexperienced users in anaesthetised patients

Acronym

Study hypothesis

Is the Tulip airway easier to use and does it provide better ventilation for unconscious patients when compared to the Guedel with facemask ventilation when used by inexperienced users?
60 inexperienced users (with Basic Life Support BLS skills) will manage the airway on 60 anaesthetised patients

Ethics approval

NRES Committee London, 11/11/2011, 11/LO/1400

Study design

Single-centre randomised cross over study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Airway management in the community and by para-medical staff is widely accepted as poor. Good airway management is fundamental to a safe outcome.

Intervention

Two different airway devices are being tested. The most common in use is the facemask. A new device (Tulip airway) works better in manikins. Ventilation parameters are measured using both devices in unconscious (anaesthetised) consented patients. The subjects are inexperienced users with BLS skills.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Parameters measured are tidal volume, peak inspiratory pressure, end-tidal carbon dioxide. Three breaths are recorded.
After anaesthesia is induced in the patient, the depth of anaesthesia is deepened until the patient has total jaw relaxation. The consultant anaesthetist doing the study confirms that the airway is manageable and that the patient can be ventilated and ventilates the patient 3 times and measures the ventilatory parameters of tidal volume, airway pressure and end tidal carbon dioxide. The inexperienced user then ventilates the patient using both devices in a randomised order. The first 3 breaths that are achieved with each device are measured using the same end-points as the consultant. The inexperienced user is given 60 seconds to achieve ventilation. The study is abandoned if there is patient compromise.
The exact time points are 3 breaths within 60 seconds oaf attempting ventilation.

Secondary outcome measures

Ease of use and airway preference by the inexperienced user is assessed.

Overall trial start date

01/04/2013

Overall trial end date

01/07/2015

Reason abandoned

Eligibility

Participant inclusion criteria

All users must have had BLS training within the last year.
All patients must be 18-70 years old, ASA 1 or 2, scheduled surgery with no risk factors for regurgitation.

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

60 users + 60 patients

Participant exclusion criteria

1. Risk of regurgitation
2. Vomiting
3. ASA status greater than 2

Recruitment start date

01/04/2014

Recruitment end date

01/04/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northwick Park Hospital
Watford Road Middlesex
Harrow
HA1 3UJ
United Kingdom

Sponsor information

Organisation

North West London Hospitals NHS Trust

Sponsor details

Watford Road
Harrow
Middlesex
London
HA1 3UJ
United Kingdom
+44 (0)20 8864 3232
neville.robinson@nhs.net

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

North West London Hospitals NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The journal Anaesthesia (AAGBI) in 2015

Intention to publish date

01/05/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes